Boston Scientific POLARx FIT BALLOON CATHETER LT US recall
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Why was Boston Scientific POLARx FIT BALLOON CATHETER LT US recalled?
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 00191506016463
- Product
- Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 368 units
- Distribution
- Worldwide
- Recall date
- November 20, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)